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Pre-Marketing Clinical Trial Experience

The safety of RAPLONTM (rapacuronium bromide) Injection was evaluated in 2036 subjects in prospective clinical trails. The majority of use in clinical trials was single bolus intravenous exposure.

Incidence of Adverse Events in Controlled Clinical Trials

The most common adverse event with an incidence of >5% seen with RAPLON (rapacuronium) TM in controlled clinical trials was hypotension (5.2%). Table 18 lists treatment-emergent signs and symptoms that occurred in at least 1% of patients receiving RAPLON (rapacuronium) TM in controlled clinical trials that were numerically more frequent than in the active control.

TABLE 18: Most Frequent Adverse Events Seen with RAPLON (rapacuronium) TM in Controlled Clinical Trials

Body System Adverse Clinical Experience

RAPLONTM

n=1956

Succinylcholine

n=572

Other Active Controls n=141

Cardiovascular

Hypotension

5.2%

6.5%

4.3%

Tachycardia

3.2%

0.52%

1.4%

Bradycardia

1.5%

1%

2.1%

Respiratory

Bronchospasm

3.2%

2.1%

0.71%

a Active Controls include rocuronium bromide, vecuronium bromide, and mivacurium

Incidence of Other Adverse Events During Premarketing Evaluation of RAPLON (rapacuronium) TM † in all Treated Patients

In the following tabulation, the frequencies represent the proportion of the 1,956 patients exposed to at least one dose of RAPLON (rapacuronium) TM who experienced an event of the type cited on at least one occasion while receiving RAPLON (rapacuronium) TM. All events reported are included except those already listed in the previous table. Although events reported occurred during treatment with RAPLONTM (rapacuronium) , a causal relationship has not necessarily been established.

Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/10000 patients.

Body as a Whole: Infrequent: fever, rigors, back pain, hypothermia, chest pain, peripheral edema, pain; Rare: asthenia, fatigue, non-inflammatory swelling, therapeutic response decrease.

Cardiovascular: Infrequent: hypertension, extrasystoles, abnormal ECG, arrhythmia, cerebrovascular disorder, ventricular fibrillation, atrial fibrillation, ventricular tachycardia; Rare: atria arrhythmia, cardiac failure, right cardiac failurem, cardio-respiratory arrest, cardiac arrest, thrombophlebitis, supraventricular extrasystoles, supraventricular tachycardia, myocardial infarction, left bundle branch block.

Digestive: Frequent: vomiting, nausea; Infrequent: ileus, saliva increased; Rare: abdominal pain, cholelithiasis, nonspecific gastrointestinal disorder, rectal hemorrhage, esophagospasm, oral hemorrhage, tooth disorder.

Hemic and Lymphatic: infrequent thrombosis, post-operative bleeding, Rare: epistaxis, coagulation factor decrease, purpura, anemia, hemoperitoneum.

Metabolic and Nutritional: Rare: acidosis.

Musculoskeletal: Infrequent: myalgia; Rare: muscle weakness, neonatal hypotonia.

Nervous: Infrequent: hyposthesia, hemiparesis, hypertonia, prolonged neuromuscular block, prolonged anesthesia emergence: Rare: headache, cerebral hemomhage, intracranial pressure increased. Migraine, ptosis, tetany, breath holding, confusion, anxiety.

Respiratory: Infrequent: hypoxia, increased airway pressure, hypoventilation, laryngismus, coughing, apnea, respiratory depression, upper airway obstruction, neonatal respiratory distress syndrome, pneumothorax, pulmonary edema, respiratory insufficiency, stridor; Rare: pharyngitis, larynx edema, dyspnea, neonatal respiratory depression, hyperventilation, minitis, sputum increase.

Skin: Frequent: erythematous rash; infrequent; injection site reaction, injection site pain, rash, urticaria, pruritis, sweating increased; Rare; paravenous injection.

Special Senses: Rare: corneal ulceration, meiosis decreased hearing.

Urogenital: Infrequent: Urinary retention, oliguria, Rare: abnormal renal function, urinary tract infection, pelvic inflammation, vaginal bleeding.